Cleared Traditional

K221360 - Medline UNITE Medial Malleolus Peg Plat...

K221360 is an FDA 510(k) clearance for Medline UNITE Medial Malleolus Peg Plat..., manufactured by Medline Industries, LP. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K221360 · Medline Industries, LP · Orthopedic device
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Sep 2022
Decision
139d
Days
Class 2
Risk

K221360 is an FDA 510(k) clearance for the Medline UNITE® Medial Malleolus Peg Plate System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on September 27, 2022 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, LP devices

FDA 510(k) Submission Details - K221360

510(k) Number K221360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2022
Decision Date September 27, 2022
Days to Decision 139 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1015
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221360.
Varixis Elbow System
K213014 · Auxein Medical Private Limited · Oct 2022
Arthrex 2.4 mm Volar Distal Radius Plate System
K222267 · Arthrex, Inc. · Oct 2022
Arthrex 3.5 mm Locking Compression Plates
K222244 · Arthrex, Inc. · Sep 2022
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809 · DePuy Synthes · Sep 2022
Bonebridge Osteosynthesis Plating System
K213864 · Bonebridge AG · Sep 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935 · I.T.S. GmbH · Aug 2022